Ostomy base plate and a method of applying an ostomy base plate

ABSTRACT

A method and a device are described for an ostomy base plate having a storage configuration as delivered to a user and a use configuration as applied to skin of the user. In the storage configuration, a proximal side of the ostomy base plate is substantially convex, and in the use configuration, the proximal side of the ostomy base plate is substantially concave.

The invention relates to an ostomy base plate. In particular, theinvention relates to an adaptable ostomy base plate for ostomies orstomas located on a bulge or hernia on the skin surface of a user.

BACKGROUND

In connection with surgery for a number of diseases in thegastro-intestinal tract, one of the consequences in many cases is thatthe patient is left with an abdominal stoma, such as a colostomy, anileostomy or a urostomy in the abdominal wall for the discharge ofvisceral contents. The discharge of visceral contents cannot beregulated at will. For that purpose, the user will have to rely on anappliance to collect the material emerging from such opening in a bag,which is later emptied and/or discarded at a suitable time.

An ostomy appliance may be in the form of a one-piece appliance forwhich a collecting bag for human body wastes is permanently, or fixedly,secured to an adhesive base plate for attachment to the human skin.Alternatively, the ostomy appliance may be a two-piece appliancecomprising a base plate and a collecting bag which may be coupled to andun-coupled from each other through a coupling means. This has the effectthat the base plate does not need to be separated from the skin of theuser as often as exchange of the collecting bag requires. The base platemay need only to be changed every third or fourth day depending on theuser, whereas the collecting bag may be changed more than once per day.Typically, it is desirable to need as few exchanges of the base plate aspossible in order to reduce the risk of skin complications.

One of the main concerns of ostomates using ostomy appliances having anadhesive base plate for attachment to the skin surrounding a stoma, andwhere a collecting bag is attached to the base plate for collectingstoma output, is that the ostomy adhesive attachment may be compromisedresulting in leakage or even complete detachment of the ostomyappliance.

Numerous attempts have been made to solve this problem and even thoughsome attempts have been partly successful, still there exist noproducts, which completely solve this problem.

One reason why this is so difficult to solve is the fact that stomas andpeoples anatomy are very different. Different considerations need to bemade for thin people than for larger people, for different skin types,for placement of the stoma, which may vary a lot from person to person,for scar tissue surrounding the stoma, for local irregular skintopography and combinations of all of the above.

Particularly in relation to persons suffering from hernia, i.e. thephenomenon that a bodily structure (e.g. the intestine) protrudesthrough a rupture in smooth muscle tissue surrounding it, experienceshows that it is often very difficult to attach an ostomy appliance tothe skin surface where the hernia is located in a manner that providessatisfactory protection against leakage from stomal fluids. It is notuncommon that the surgical procedure undertaken to make a stoma on apatient also results in a weakening of the muscle tissue of the stomachwall which may consequently lead to the formation of a hernia where thestoma is located on the skin surface (or close or adjacent to thestoma).

In some cases where the stoma is located on a hernia, an additionalcomplication may occur as gravity forces the protruding intestinesdownward and consequently also force the involved skin surface downward.Thereby, a stoma located on the hernia may begin to “point” downward(i.e. towards the user's feet) depriving the user of direct visualcontact with the stoma and/or the peristomal skin surface. This is ofcourse a great disadvantage for users applying their product themselves(which is the great majority of users) since the risk of misalignment orimproper positioning of the product is largely increased. As aconsequence, in such cases leakage problems may occur much morefrequently.

Moreover, a hernia is not a static phenomenon. It is almost certainnever to take a perfect geometrical shape but instead often has a highlyirregular topography. This may be caused by many factors such asconditions in the physical surroundings of the user, level of activityof the user and contents of the bowels at any given time, just tomention a few.

In addition to the formation of hernias, other physical conditions orpathologies may also mean or lead to irregular skin topography such asbulges or otherwise “hilly” stomach skin surface, the causes includinge.g. trauma and/or obesity.

DESCRIPTION OF RELATED ART

US 2012/0323193 discloses a one-piece ostomy device where the ostomypouch is coupled to the wafer by a radially outwardly extending couplinglayer. The configuration of the wafer is flat.

U.S. Pat. No. 4,419,100 discloses an ostomy appliance where the couplingmeans for the ostomy pouch is coupled to the faceplate by a radiallyinwardly extending web, the web allowing limited floating action betweenthe coupling and the faceplate.

SUMMARY OF THE INVENTION

The present invention provides a base plate to be used as part of orwith an ostomy appliance. Particularly, the invention provides havingone or more sections having a shape that can be adapted or physicallyaltered from one shape to another in order to both assist the user inapplying the base plate in an easier manner and to achieve a better fitto the body. The base plate is especially advantageous to be used onusers suffering from and having their stoma located on a non-planar andnon-regular skin surface. The base plate is provided with coupling meansfor attaching a collection bag.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a schematic distal view of an ostomy base plate according toembodiments of the invention,

FIG. 2 is a schematic cross-sectional view of an ostomy base plate instorage configuration, according to embodiments of the invention,

FIG. 3 is a schematic cross-sectional view of the ostomy base plate inFIG. 2 in use configuration, placed on the skin surface of a user,

FIG. 4 is a schematic isometric view of an ostomy base plate accordingto the embodiments introduced in FIG. 1 shown in use configuration.

FIG. 5 is an enlarged view of a section of FIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

For interpretations in the context of the present application, somedefinitions regarding the subject matter of the attached claims arepresented below.

When referring to the proximal side of a device or part of a device, thereferral is to the skin-facing side, when the ostomy appliance is wornby a user. Likewise, whenever referring to the distal side of a deviceor part of a device, the referral is to the side facing away from theskin, when the ostomy appliance is worn by a user. In other words, theproximal side is the side closest to the user, when the appliance isfitted on a user and the distal side is the opposite side—the sidefurthest away from the user in use.

The axial direction, or axially, is defined as the direction of thestoma when the appliance is worn by a user. Thus, the axial direction issubstantially perpendicular to the abdominal surface of the user.

The radial direction, or radially, is defined as transverse to the axialdirection that is transversely to the direction of the stoma.

An “adaptable ostomy base plate” is intended to define that at least apart of the ostomy base plate can change its form or shape by anintended interaction of a user or health care professional.

A “flexible top film” is intended to define a film material carrying orhaving disposed thereon, adhesive material to make the product adhere tothe skin of a user and that the top film material does not break orbecome weaker even at very high elongation or stretching rates. Aflexible top film is further defined below.

An “elastic skin-friendly adhesive” is intended to define an adhesivematerial having a low risk of irritating the skin of a user and that theadhesive material is capable of following the elongations andrelaxations of the flexible top film without breaking or substantiallychanging characteristics. An elastic skin-friendly adhesive is furtherdefined below.

An “adhesive wafer” is intended to define a top film coated on theproximal surface with a skin-friendly adhesive.

A “substantially convex shape” is intended to define that an element orits corresponding surface has a shape or form that provides an overallconvexity. In other words, while a smaller section or zone making uppart of the overall element or its corresponding surface may have e.g. alinear shape or form, the element or surface as a whole has a convexshape. It is of course to be understood that if for a sheet- orplate-like element one major surface has a convex shape, the oppositemajor surface may necessarily have a corresponding concave shape.However, for clarification purposes only, and in relation to the presentapplication, “convex” may preferably refer to the proximal side and“concave” to the distal side as both defined above.

Similarly, a “substantially concave shape” is intended to define that anelement or its corresponding surface has a shape or form that providesan overall concavity.

“Initial engagement” is intended to define the first contact between theostomy base plate and the skin surface of the user in the process ofapplying the product; however not meaning that the ostomy base plate isfully and functionally correct attached to the skin surface.

“Permanent engagement” is intended to define the engagement orattachment of the ostomy base plate when the application process iscompleted and the ostomy base plate is fully and functionally correctattached to the skin surface. However, it should be understood thatpermanent engagement is only intended to mean for the normal life- orwear time of the ostomy base plate.

“Release liner” is intended to define a liner covering the proximal(skin contacting) side of the skin-friendly adhesive, that ensures atleast that the properties of the adhesive are preserved and that theadhesive surface is not laid open until just before the use.

“Fittingly engage” is intended to define that the attachment between theostomy base plate and the skin surface is as good as possibly feasibleand at least with no or only insignificant creases or folds on theproximal surface of the base plate.

“Peristomal skin surface” is intended to define an area of the skinsurface adjacent to and surrounding the stoma. The extent of the areamay be considered to correspond approximately to a skin surface areacovered by at least a first section of the ostomy base plate—the firstsection then being closer to the stoma than a second section.

“Invertible” is intended to define that the at least first and/or secondsection provides little or no resistance to being shifted from asubstantially convex shape to a substantially concave shape, or viceversa, by a movement involving no sudden switching or “flipping-over” ofthe section (i.e. as it is known from a bi-stable construction which maychange shape when a certain force-threshold is reached).

“Store configuration” is intended to describe the position of the baseplate before application is completed. The base plate is stable in thisconfiguration and can be stored in this configuration. In the initialsteps of application, the base plate may be in store configuration.

“Use configuration” is intended to describe the position of the baseplate after application is completed, and is the inverted configurationof the store configuration. The coupling means are forced into closecontact with the base plate in this configuration.

In a first aspect, the invention relates to an adaptable ostomy baseplate comprising a flexible top film and having at least a firstsection, at least a first elastic skin-friendly adhesive on a proximalsurface of said flexible top film, a stoma-receiving through-going holein said first section, said first section being adjacent to andextending radially from said through-going hole, at least said firstsection has a first substantially convex shape for initial engagementwith a peristomal skin surface, at least said first section beinginvertible to a first substantially concave shape to fittingly engagesaid first section to a topography of the peristomal skin surface forpermanent engagement thereto, the base plate further comprising distallyfirst coupling means for coupling engagement with corresponding couplingmeans on a collecting bag for human body wastes, the coupling meansbeing radially to the hole, the first coupling means being attached toan inner periphery of a radially outwards extending connecting elementand an outer periphery of the connecting element is attached to the topfilm, wherein the connecting element has a substantially concave shape.

The connecting element comprises an inner periphery for connection withthe coupling means, a middle portion being unattached to the top filmand the connecting element and an outer periphery being connected to thetop film. Thus, the connecting element is only attached at is peripheralportions, which allow flexibility during application of the base plateand decreases the risk of deformation of the base plate during storage.The concave shape of the connecting element may elevate the couplingmeans with regard to the top film when this is in store configuration.

The coupling means may be in the form of a mechanical coupling or it maybe an adhesive coupling.

The base plate may have any suitable shape, such as a substantiallycircular or oval outline.

The radius of the outer periphery of the connecting element is largerthan the radius of the inner periphery. The outer periphery may have aradius being at least 1 mm, such as 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm,8 mm, 9 mm or even 10 mm larger than the radius of the inner peripheryof the connecting element. In one embodiment the radius of the outerperiphery of the connecting element is between 1-20 mm, such as 1-15 mm,such as 2-15, such as 5-15 mm, such as 2-10, such as 3-6, such as 5-10mm or even 1-5 mm.

The connecting element may be in the form of a polymer film or a web.The connecting element may be flexible enough to follow the base platewhen it is inverted, but yet firm enough not to stretch due to forcesinduced by a filled collection bag. In one embodiment, the connectingelement is a flexible film.

The connecting element may be integrated with the coupling means, forexample being molded together with the coupling means, being a singleunit.

A radially outwardly connecting element may divert pulling forces fromthe collection bag away from the peripheral portions of the base platethereby decreasing the risk of the plate peeling off.

Furthermore, when the device is inverted from the initial convexconfiguration to the concave configuration, the outwardly connectingelement will pull the coupling means tightly towards the base plate andthe skin, thereby preventing the collection bag to fall forward.

The construction with the outwardly connecting element between thecoupling means and the base plate stabilizes the collection bag withregard to the base plate but still provides flexibility duringapplication.

The “central portion” of the top film being herein defined as theportion of the adhesive coated top film being bounded by the attachmentline of the inner periphery of the connecting element.

The attachment line of the connecting element to the top film defines ahorizontal plane being substantially parallel to the skin. Theconnecting element defines an angle to the plane of the attachment linebeing substantially equal to the angle defined by the central portion ofthe top film and the plane of the attachment line. By substantiallyequal is meant that the angles deviates less than 10 degrees from eachother's.

In storage configuration the central portion of the top film is convexand the connection element is concave and free space may be left betweenthe top film and the coupling means. When the base plate is invertedinto use configuration, the coupling means will be pulled towards thecentral portion of the top film as both the top film and the connectingelement is now concave.

In storage configuration, the coupling means may possess a certainflexibility with respect to the top film. When the base plate isinverted into use configuration during application, the coupling meanswill be dragged into close contact with the top film and be firmly fixedat this position. By “firmly fixed” is meant that the coupling meanscannot be moved or displaced with regard to the top film. The connectingelement may be stretched and further facilitate holding the connectingmeans firmly in place.

The distance along the central portion of the top film measured from oneopposing attachment point along the outer periphery of the connectingmeans (the diameter of the attachment line) is substantially the same asthe radial distance of the coupling means combined with the connectingmeans. By substantially the same is meant that the distances deviatesless than 5%. The distance of the combined connecting means and couplingmeans may be slightly longer than the distance measured along thecentral portion of the top film from one opposing attachment point alongthe outer periphery of the connecting means in order to ensure thatunwanted pulling forces may occur along the attachment line when thedevice is inverted into use configuration.

Due to the equal distances of the coupling means combined withconnecting element and the central portion of the top film beneaththese, the coupling means will be firmly held towards the topfilm—though not physically adhered or welded to the top film—when thebase plate is inverted during application.

In a second aspect, the invention relates to an adaptable ostomy baseplate comprising a flexible top film and having at least a firstsection, at least a first elastic skin-friendly adhesive on a proximalsurface of said flexible top film, a stoma-receiving through-going holein said first section, said first section being adjacent to andextending radially from said through-going hole, the base plate furthercomprising distally first coupling means for coupling engagement withcorresponding coupling means on a collecting bag for human body wastes,the coupling means being radially to the hole, the first coupling meansbeing attached to the base plate via a radially outwards extendingconnecting element, wherein at least said first section has a firstsubstantially convex shape for initial engagement with a peristomal skinsurface, at least said first section being invertible to a firstsubstantially concave shape to fittingly engage said first section to atopography of the peristomal skin surface for permanent engagementthereto and wherein the coupling means are movable with respect to thetop film when the base plate is in convex shape and unmovable when thebase plate is in concave shape.

By the invention according to the first aspect, a number of advantageouseffects are achieved. First of all, a user having a stoma located on abulge or hernia, or on an otherwise “hilly” topographic skin surface,has improved control of the product application procedure.

This effect is at least partly achieved in the following manner:subsequent to removal of at least one release liner covering at leastpartly the first section, the user engages a part of the first sectionimmediately adjacent the stoma-receiving through-going hole with theperistomal skin surface, whereby only a small area of the adhesive onthe proximal surface of the flexible top film is engaged with theperistomal skin surface.

Thereby, the user is provided with the opportunity to correct thepositioning of the ostomy base plate to a more suitable position in caseof misalignment of the initial engagement without having engaged thewhole of the proximal adhesive surface of the flexible top film with theskin surface. This may be particularly advantageous in cases where theuser has limited or no visual contact with the stoma.

Furthermore, since at least the first section has a first substantiallyconvex shape, a user reaching down to the stoma located on the bulge orhernia in order to apply the product will have improved tactile and/orvisual contact with the stoma and/or the peristomal area. This isbecause the part of the first section not initially engaging theperistomal skin surface extends away from the skin surface, thus leavingsome space between the base plate and the skin, giving room for one ormore of the user's fingers, and thereby the first section also does notblock or impede possible visual contact for correct positioning of thebase plate in relation to the stoma.

Once the initial engagement of the first section is effected, theinvertible first section is inverted by the user to a firstsubstantially concave shape so as to fittingly engage the first sectionwith the peristomal skin surface on the bulge or hernia.

It is important to understand the manner in which this is done. Due tothe flexibility of the flexible top film and the elasticity of theskin-friendly adhesive, the adhesive proximal side of the first sectionwill adapt smoothly to the topography of the peristomal skin surfacewhen the user applies a gentle pressure to the distal surface of thefirst section.

This may advantageously, but not exclusively, be done by the userletting his finger or fingers describe one or more radial motions byplacing the finger(s) immediately adjacent the stoma, providing pressureto the distal surface, and sliding the finger gently across the distalsurface of the first section radially away from the stoma.Alternatively, the adaptation may be done by a motion placing a fingerimmediately adjacent the stoma, providing pressure to the distalsurface, and sliding the finger gently in a “spiral-like” patterngradually away from the stoma over the entire distal surface of thefirst section.

However, regardless of the way of adaptation, at least the flexibilityof the flexible top film and the elasticity of the skin-friendlyadhesive along with the first substantially convex shape of the firstsection make the fitting engagement of the first section possible.

As can be understood from the above, the flexible top film and theelastic skin-friendly adhesive facilitate the inversion of the firstsection for application to the peristomal skin surface by a continuous,regular movement (or movements). This provides a user with improvedcontrol of the application procedure. This should be seen in contrast toa sudden movement which would be the case e.g. in the case of abi-stable construction, i.e. a construction having one predeterminedposition where it changes shape from one form to another, e.g. fromconvex to concave.

When the base plate is inverted from the convex to the concave shape,the coupling means will be pulled towards the top film and lye firmlyagainst this when the base plate is in inverted position. But due to thelimited area of attachment, and the attachment being at a distance fromthe hole, the flexibility is high and the peeling effect is low.

The flexible top film according to the invention may be a blown filmprimarily based on one or more Ethylene Vinyl Acetate (EVA) materials,one or more thermoplastic polyurethane elastomer (TPU) based materialsand one or more polyethylene (PE) materials. Particularly, but notexclusively, the EVA and TPU based materials may provide a good basisfor engagement of the top film with other elements of the ostomy baseplate such as the adhesive(s) and optional first coupling means, or inthe case of the base plate being used for a one-piece ostomy appliance,with the material of the collecting bag for human body wastes. The PEmaterial(s) may particularly, but not exclusively, provide a suitablebasis for shaping the flexible top film into a convex or concave shapeto be able to fittingly engage with a topography of a user's skinsurface.

In embodiments, the flexible top film is a three-layer laminate.

Particularly, but not exclusively, the flexible top film may be made asa laminate comprising three individual (blown) layers each of which ismade from either EVA, TPU or PE or from a blend of these. In thethree-layer laminate, the distal-most (with reference to the usesituation of the ostomy base plate) layer may be made from a blend ofElvax® 3190, an EVA material from DuPont, and Orevac® 18360, a PEmaterial from Arkema; the middle layer may be made from a blend ofElvax® 3190, Elastollan® 890, a TPU-Polyester material from BASF andElastollan® 978, another TPU-Polyester material from BASF and; theproximal layer may also be made from a blend of Elvax® 3190, Elastollan®890 and Elastollan® 978. In addition to these components each of thedistal and proximal layers of the three-layer laminate may also comprisea minor amount of slip agent (to assist when unrolling the top filmmaterial for production of the ostomy base plate). The slip agent may bea PE/EVA polymer carrier containing silica, oleamid (fatty acid oleicacid) and erucamide (monounsaturated omega-9 fatty acid), such asPolystatic® 90200-2. The silica and the ole-/erucamides in the slipagent provide the slipping effect.

The overall thickness of the flexible top film may be in a range of30-70 μm, such as 35-50 μm, such as approximately 40 μm. In embodimentsof the three-layer laminate, each individual layer may have a thicknessof at least 10 μm for ease of production of the individual layers.

The flexible top film may be stretched prior to being used in theproduction of the ostomy base plate. This will provide a pre-tensioningor bias in the flexible top film. The flexible top film may be stretchedradially in all directions to obtain the same bias in all directions ofthe plane thereof. This pre-tensioning or bias in the flexible top filmincurs additional flexibility to the flexible top film. Particularly, itmay improve the film's ability to adapt to a certain shape in a shapingprocess.

The flexible top film may have a flexibility measured as a percentage ofelongation of the flexible top film material before it fails (consideredas the point where plastic deformation of the flexible top film occurs).The flexible top film may be 250-700% elongatable, such as 300-600%elongatable, such as 350-450% elongatable, such as 400% elongatablebefore failure.

The first elastic skin-friendly adhesive according to the invention maybe a pressure sensitive adhesive composition suitable for medicalpurposes comprising a rubbery elastomeric base and one or more watersoluble or water swellable hydrocolloids, the adhesive compositioncomprising a substantially homogeneous mixture of 25-60% of one or morepolyisobutylenes, 3-35% of one or more styrene copolymers, and 20-60% ofone or more hydrocolloids, wherein the percentage by weight of one ormore polyisobutylenes and one or more styrene copolymers and one or morehydrocolloids add up to 100% by weight of the adhesive composition. Forfurther information on such compositions reference is made toapplicant's granted European patent EP1541180B1.

The thickness of the first elastic skin-friendly adhesive layer may bein a range of 1-2 mm, corresponding to 1000 μm-2000 μm, such as 1200μm-1800 μm, such as 1400 μm-1600 μm.

For the production of the ostomy base plate, the following is an exampleof manufacture: first the adhesive(s) is/are provided on the proximalsurface of the flexible top film and thereafter the at least one releaseliner is provided on the adhesive surface. At least the first section ofthe planar laminate blank is then subsequently placed in avacuum-forming machine, the moulding tool having the relevant convexform. Heating means, such as a radiant heat source is placed inconnection with the vacuum-forming machine in order to soften thelaminate blank, and the laminate blank is subjected to heat and vacuumforming for an adequate holding time. Alternatively, the laminate blankmay also be manufactured by means of a heat and pressure die or indeedany other suitable procedure.

In embodiments where the second section of the ostomy base plate is alsoconvex shaped (or concave shaped) the moulding tool used in the processdescribed above may be configured to provide both convex shapes (orconvex shape of the first section and concave shape of the secondsection). Alternatively, the shaping process may be divided into moresteps, e.g. first shaping the first section and separately shaping thesecond section. The stoma-receiving through-going hole may be cut in theostomy base plate before or after the shaping process.

Due to its elasticity, the first skin-friendly adhesive may easily adaptto the convex shape of at least the first section together with theflexible top film and the at least one release liner in the shapingprocess. Indeed, subjected to the above described shaping process, atleast the first section of the ostomy base plate according to theinvention initially always has the convex shape notwithstanding its highdegree of adaptability. As mentioned, this may be seen in contrast toe.g. the known bi-stable convex ostomy products that are relativelyrigid and only adaptable in an “either inverted/not inverted” sense.

The at least one release liner used in connection with the ostomy baseplate according to the invention, may suitably be a siliconised orfluorinated liner, such as a siliconised or fluorinated craft paper,polyethylene, polypropylene or polyethylene terephthalate film.

In embodiments, the second section has a second substantially convexshape being invertible to a second substantially concave shape.

This may be particularly advantageous to further improve the tactileand/or visual contact with the stoma and/or the peristomal area. In suchembodiments, where then both the first and the second sections initiallyextend away from the skin surface, there will be additional spacebetween the base plate and the skin giving plenty of room for the user'smanual handling of the base plate during application. Also, thereby thesecond section does not block or impede the user's visual contact withthe stoma.

The second section may be inverted and permanently engaged to the skinsurface of the user in the same or substantially similar manner as thefirst section and as described above. The engagement of the secondsection to the skin surface is generally carried out after the firstsection has been permanently engaged with the peristomal skin surface.However, in the case of a two-piece ostomy appliance, it may beadvantageous to engage the second section to the skin surface of theuser only after the collecting bag has been coupled to correctengagement with the ostomy base plate.

The second section surrounds the first section of the adaptable ostomybase plate. In embodiments, a transition between the first and thesecond section may be defined by a zone where the two convex sectionsmeet at an angle to each other.

This may be particularly, but not exclusively, advantageous if easydistinction of the sections by the user is required, e.g. facilitatingthe user's following of instructions for use.

In other embodiments, the transition may be straight or smooth (i.e. noangle between the sections) thus ruling out at least any visualdifference between the sections. If the first and second sections arearranged according to such embodiments there may be no differencebetween the convexity of the first and second section, thus the firstand second section may be perceived, or actually manufactured, as asingle “coherent” or integral convex section. This may be particularlyrelevant in relation to minimizing production costs.

Additionally, however, the first and the second section may havedifferent convexities. This could by way of example be relevant inrelation to different dimensions and/or sizes of the ostomy base plate.

In embodiments, the second section has a second substantially concaveshape. This should be seen in contrast to the embodiments describedabove wherein the second section is invertible to a second substantiallyconcave shape. Therefore, in these embodiments the second section has apre-defined substantially concave shape. A transition between the firstand second section is defined by a zone where the two sections meet atan angle to each other. Consequently, the initial substantially convexshape of the first section makes the first section extend away from theskin surface, while the substantially concave shape of the secondsection makes the second section extend toward the skin surface from theposition of the transition between the sections.

In embodiments, the ostomy base plate according to the invention furthercomprises a substantially planar surface zone between said first andsecond sections.

“Substantially planar” is intended to define that a surface zone of theostomy base plate has a linear or planar form close to parallel with astraight horizontal line; at least it is not inclined in relation tosuch horizontal line by more than +/−10 degrees. At least thisdefinition is meant to clearly identify that the surface zone does notpossess any kind of convex or concave shape in contrast to the first andsecond section.

The substantially planar surface zone between the sections may provideextra control with regard to the user's handling of the product in theapplication procedure and may further hinder that the first and/or thesecond sections become obstructive in e.g. the distal or proximaldirection with regard to e.g. the user's clothes or with regard to otherobjects or other physical areas of contact on the user's body. This maybe particularly, but not exclusively, efficient, if a relatively largeadhesive area of the ostomy base plate is needed (e.g. for high-volumeoutput collecting bags).

The substantially planar surface zone may form at least part of a firsttransition between the first section and the zone and/or form at leastpart of a second transition between the second section and the zone.

The first coupling means may be in the form of a mechanical coupling,comprising an annular ring having a flange or similar member extendingaxially away from the planar surface zone to engage with engaging secondcoupling means on a collecting bag such as a corresponding annular ringwith a channel for receiving the flange. Alternatively, the coupling maybe an adhesive coupling where the first coupling means may comprise aradially extending annular flange that provides a receiving surface forreceipt of second coupling means on a collecting bag such as an annularadhesive flange. However, these are mere examples of typical couplingmeans for ostomy appliances; others types of engaging coupling means arenot to be considered excluded.

The first coupling means are not directly joined to the substantiallyplanar surface, but are joined through the connecting element to thesurface by welding, heat laminating, gluing or other commonly knownsuitable joining procedures. The first coupling means are joined throughmeans of the connecting element, for example in the form of a filmmaterial attached to the substantially planar surface at the outerperiphery and to the first coupling means at the inner periphery.

In embodiments, the adaptable ostomy base plate comprises a secondskin-friendly adhesive on the proximal surface of the flexible top film.

The second skin-friendly adhesive may be provided so as to give theproximal surface of the base plate different characteristics and/oreffects. As an example, the second skin-friendly adhesive may comprisesmaller or a larger amount of a moisture absorbing component such ashydrocolloids and/or be more or less adaptable than the firstskin-friendly adhesive. The second skin-friendly adhesive may beprovided in a single or in multiple zones or areas. The zones or areasmay have particular suitable shapes or forms depending on the functionor effect of the second skin-friendly adhesive.

In embodiments, the first elastic skin-friendly adhesive is provided onthe first section and the second skin-friendly adhesive is provided onthe second section.

This disposition of the first and second skin-friendly adhesiveeffectively provides an ostomy base plate wherein the firstskin-friendly adhesive having one set of characteristics covers theperistomal area, and the second skin-friendly adhesive having anotherset of characteristics covers the skin surface around (radially beyond)the peristomal skin surface.

In embodiments, the second skin-friendly adhesive is elastic. Thismeans, that in addition to the first elastic skin-friendly adhesive,also the second skin-friendly adhesive has elastic properties. Thesecond skin-friendly adhesive may be more or may be less elastic thanthe first elastic skin-friendly adhesive or the two adhesives may evenhave identical elasticities if desired.

Where the elasticity of a construction is typically measured by thetensile elasticity Modulus (E) (also known as Young's Modulus) theelasticity of an adhesive is typically measured by the shear Modulus(G).

The shear Modulus of a viscoelastic material like an adhesive can bedivided into a viscous part called the Loss Modulus (G″) and an elasticpart called the Storage Modulus (G′). The elastic response of theadhesives can therefore be measured by measuring G′ by dynamicmechanical analysis (DMA), which is a well-known and establishedprocedure to a skilled person working in the field of adhesives.

Body movements according to normal daily life routines typically occurat frequencies around 1-10 Hz. At these frequencies, the G′ of the firstelastic skin-friendly adhesive may be in a range from 850-1200 MPa,whereas G′ of the second elastic skin-friendly adhesive may be in arange from 40-80 MPa.

In embodiments, the second elastic skin-friendly adhesive comprises apolar plasticising oil or a combination of polar plasticising oils inthe content of above 10% (w/w) of the final second adhesive, and atleast one polar polyethylene copolymer, wherein the content of thepolyethylene copolymer is 10-50% (w/w) of the final second adhesive, thepolyethylene copolymer has a melt flow index below 2 g/10 min (190°C./21.1 N).

Polymers that may be used for the second skin-friendly adhesive willgenerally be copolymers of ethylene and a polar monomer. The copolymerstypically comprise less than about 70% ethylene, have water vapourtransmission of more than 50 g/m²/day and a melt flow index of less than2 g/10 min (190° C./21.1 N). The melt flow index can be measured by themethods given in ISO 1133 and ASTM D1238. Examples of such polymers arecopolymers of ethylene and vinyl acetate and copolymers of ethylene andbutyl acrylate. Particularly preferred is ethylene and vinyl acetatecopolymers with more than about 40% (w/w) vinyl acetate, a melt flowindex of less than 2 g/10 min (190° C./21.1 N), and a water vapourtransmission of more than 50 g/m²/day for a 150 μm sheet when measuredaccording to MVTR Test Method (inverted cup method).

Polar oils, which may be used in the invention, will generally be thosethat have good solubility in the polar domains of the polymer, i.e.provide softness without sacrificing too much tensile strength of thepolymer. Oils that can support good water vapour permeability arepreferred. Examples of such oils are vegetable and animal oils andderivatives thereof. Preferred polar oils are esters, ethers and glycolsand particularly preferred is Poly Propylene Oxide, e.g.alpha-butoxy-polyoxypropylene.

Further information on the types of adhesives suitable for the secondskin-friendly adhesive disclosed in these embodiments is available inapplicant's published application WO 2009/006901A1.

In embodiments, the thickness of the second elastic skin-friendlyadhesive is 300-700 μm, such as 550-650 μm, such as 600 μm.

Particularly, when using the above defined polyethylene copolymer basedadhesive as the second elastic adhesive in the thickness of 300-700 μm aflexible and soft adhesive base plate which can be handled without astiffening, or stabilizing, layer is achieved. For further informationon the combination of such a thickness range and the definedpolyethylene copolymer, reference is made to applicant's publishedapplication WO 2012/022352A1.

In embodiments, at least the second section further comprises areinforcing element. Thereby, the second section may be easier to handlebecause it is at least partly stiffened or stabilized by the reinforcingelement. Particularly in the case of a relatively large (diameter)ostomy base plate according to the invention this may help the user tocontrol the product. By way of example, the reinforcing element could bea permeable or perforated film layer such as of a blown film but alsoincluding non-wovens or foamed film layers. The reinforcing element maybe embedded in the second skin-friendly adhesive or located between thedistal surface of the adhesive and the proximal surface of the flexibletop film.

DETAILED DESCRIPTION OF THE DRAWING

Initially, it shall be noted that the figures are schematicillustrations intended only to address the principles and functions ofthe base plate according to the invention and are not to be consideredlimiting to the scope of the attached claims. Furthermore, the figuresand particularly the individually illustrated elements are notnecessarily to scale, neither individually nor in relation to eachother.

FIG. 1 shows an adaptable ostomy base plate seen from the distal sideaccording to embodiments of the invention. The base plate comprises aflexible top film (1) coated on the proximal surface with a skinfriendly adhesive. The distal surface of the base plate comprisescoupling means (3) for attachment to a collecting bag (not shown). Thecoupling means (3) are connected to the top film (1) through an outwardsextending element (2), extending from the coupling means (3) andradially outwards. The central portion is provided with a hole (4) foraccommodating a stoma. The base plate may optionally be provided withmeans for attaching a belt (5).

FIG. 2 shows an embodiment corresponding to the one of FIG. 1, butwithout means for attachment of a belt, in cross-section, in a convexconfiguration for storage and application. The inner periphery (7) ofthe connecting element (2) is attached to the coupling means (3) and theouter periphery (6) is attached to the top film (1). Thus, the couplingmeans (3) are not connected directly to the top film (1) but areconnected via the intermediate connecting element (2). The couplingmeans (3) shown in this embodiment is a mechanical coupling. Thecoupling means comprises a first part extending distally from the deviceand a “second part extending radially and substantially perpendicularlyfrom the first part and being attached or integrated with the connectingelement.

The connecting element (2) is only attached at its inner and outerperiphery (7,6); whereas the middle portion between the inner and outerperipheries (7,6) remains unattached. The adhesive coated top film (1)defines a convex shape, like a cup or bowl or a section of a sphere,extending in distal direction. This enables the base plate to bepositioned correctly around the stoma without bringing the entireadhesive surface of the top film (1) in contact with the surroundingskin. The connecting element is concave; thereby lifting the couplingmeans a distance away from the central portion of the top film.

When the base plate has been correctly positioned around the stoma, thebase plate (1) is inverted into a concave configuration as shown in FIG.3 and the remaining adhesive surface is attached to the peristomal skin.When the base plate (1) is inverted, the coupling means (3) will bepulled towards the wafer and held tight in close contact with the topfilm. In this position, the movability of the coupling means (3) withregard to the top film is limited, and prolapse of the coupling means(3) is avoided. A collection bag (not shown) may then be attached to thebase plate (1) via the coupling means (3).

FIG. 4 shows a perspective view of the base plate (1) in the concave useconfiguration.

FIG. 5 shows an enlarged view of the connecting element (2) in storageconfiguration. The coated top film of the base plate (1) defines aconvex cup shape. The coupling means (3) may be spaced apart from thetop film but connected via the connecting element (2). The connectingelement (2) is attached to the top film by a section (8) beingsubstantially parallel to the top film. If the coupling means (3) hadbeen directly attached to the top film, the flexibility or the devicewould have been lower as well as the coupling means (3) may havedeformed the base plate, due to the force induced at the attachmentzone.

The connecting element (2) is extending from the attachment line alongthe outer periphery (6) and inwardly towards the inner periphery (7)being attached to the coupling means (3), the connecting element (2)thereby defining concave shape in the form of a line or slightly curvedline. The connecting element may define a shape correspondingsubstantially to a mirror image of the underlying central portion of thetop film. In this way, the radial distance of the top film, measuredfrom one opposing attachment point of the outer periphery of theconnecting means to another is substantially the same as the radialdistance of the coupling means combined with the connecting means. Bysubstantially the same is meant that the distances deviates less than5%.

As can be seen from FIG. 5, showing an enlarged view of a cross-sectionof FIG. 2, the connecting element (2) defines an angle (a) with theplane of the outer periphery (6) of the connection element. The baseplate under the coupling connection element forms an angle (b) with theplane of the outer periphery of the connection element. If the angle (a)is substantially larger than the angle (b), the coupling means may notbe totally fixed when inverted, but may be able to move more or lesswith respect to the base plate as well as the bag may prolapsed from thebody when filled, which is undesired. However, the angle a may beslightly larger than the angle b without compromising the fixation ofthe connecting means in the case of a thick layer of adhesive.

If the angle (a) is substantially smaller than angle (b), the base platemay be deformed at the attachment line due to the forces from thecoupling means during store position dragging the attachment lineinwards, as well as excessive stress and tension will be introduced whenthe base plate is inverted.

The connecting element may be flexible and/or elastic it may cope forangle (a) being slightly smaller than angle (b).

The invention claimed is:
 1. An ostomy base plate having a storageconfiguration as delivered to a user and a use configuration as appliedto skin of the user, the ostomy base plate comprising: a film with ahole formed through the film, where the hole is adapted for placementaround a stoma of the user; adhesive applied around the hole on aproximal side of the film; and a coupling connector secured to a distalside of the film, the coupling connector including a connecting elementhaving an outer periphery connected to the distal side of the film andan intermediate bridge extending from the outer periphery to a couplingring, where the coupling ring surrounds the hole formed through thefilm; wherein, in the storage configuration, the adhesive applied on theproximal side of the film is in a substantially convex shape with theintermediate bridge and the coupling ring spaced apart from the distalside of the film; wherein, in the use configuration, the adhesiveapplied on the proximal side of the film is in a substantially concaveshape with the intermediate bridge and the coupling ring in contact withthe distal side of the film.
 2. The ostomy base plate of claim 1,wherein the coupling ring is adapted to couple with a waste collectingbag.
 3. The ostomy base plate of claim 1, wherein the coupling ring iscircular, and a diameter of the coupling ring is larger than a diameterof the hole formed through the film.
 4. The ostomy base plate of claim1, wherein the connecting element adapts the ostomy base plate to beinvertible between the storage configuration and the use configuration.5. The ostomy base plate of claim 1, wherein the connecting elementadapts the ostomy base plate to fittingly engage with a topography ofthe skin of the user around an entire perimeter of the stoma.
 6. Theostomy base plate of claim 1, wherein the coupling connector is attachedto the distal side of the film only at the outer periphery of theconnecting element.
 7. The ostomy base plate of claim 1, wherein theconnecting element is a film.
 8. The ostomy base plate of claim 1,wherein the adhesive is elastic.
 9. The ostomy base plate of claim 1,wherein the film is a three-layer laminate.
 10. A method of applying anostomy base plate, the method comprising: providing the ostomy baseplate in a storage configuration presenting a proximal side of theostomy base plate in a substantially convex shape; providing a couplingconnector secured to a distal side of the ostomy base plate with acoupling ring of the coupling connector spaced apart from the distalside of the ostomy base plate; adhering a portion of an adhesive appliedon the proximal side of the ostomy base plate to a peristomal skinsurface and leaving a perimeter of the ostomy base plate spaced awayfrom the peristomal skin surface; and inverting the ostomy base plate toa use configuration, and inverting the adhesive applied on the proximalside of the ostomy base plate to a substantially concave shapecontacting skin of a user such that the coupling ring of the couplingconnector touches the distal side of the ostomy base plate.
 11. Themethod of claim 10, further comprising fittingly engaging thesubstantially concave shape of the proximal side of the ostomy base totopography of a hernia of the peristomal skin surface.
 12. The method ofclaim 10, further comprising correcting a misalignment of the proximalside of the ostomy base plate to the peristomal skin surface byrepositioning the portion of the adhesive applied on the proximal sideof the ostomy base plate to an area of the peristomal skin surface. 13.The method of claim 10, further comprising instructing a user to move afinger in a radial motion along the distal side of the ostomy base plateand fittingly engaging the proximal side of the ostomy base plate onto abulge in the peristomal skin surface.
 14. The method of claim 10,further comprising attaching a waste collecting bag to the coupling ringof the ostomy base plate.
 15. An ostomy base plate having a storageconfiguration as delivered to a user and a use configuration as appliedto skin of the user, the ostomy base plate comprising: a film with ahole formed through the film, where the hole is adapted for placementaround a stoma of the user; adhesive applied around the hole on aproximal side of the film; and a coupling connector secured to a distalside of the film, the coupling connector including a connecting elementhaving an outer periphery connected to the distal side of the film andan intermediate bridge extending from the outer periphery to a couplingring, where the coupling ring surrounds the hole formed through thefilm; wherein, in the storage configuration, the adhesive applied on theproximal side of the film is in a substantially convex shape with theintermediate bridge and the coupling ring spaced apart from the distalside of the film; wherein, in the use configuration, the adhesiveapplied on the proximal side of the film is in a substantially concaveshape with the intermediate bridge and the coupling ring in contact withthe distal side of the film; wherein the adhesive is an elasticadhesive.